Condition category
Mental and Behavioural Disorders
Date applied
03/08/2008
Date assigned
19/02/2009
Last edited
16/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.easp.es/pepsa

Contact information

Type

Scientific

Primary contact

Dr Eugenia Oviedo-Joekes

ORCID ID

Contact details

School of Population and Public Health
University of British Columbia
Centre for Health Evaluation & Outcome Sciences
St. Paul's Hospital
620-1081 Burrard Street
Vancouver
BC
V6Z 1Y6
Canada
+1 604 682 2344 Ext 62973
eugenia@mail.cheos.ubc.ca

Additional identifiers

EudraCT number

2005-002896-33

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy of prescribed injected diacetylmorphine in the Andalusian trial: responders and non-responders evaluated using a multi-domain outcome index

Acronym

PEPSA

Study hypothesis

The impact of intravenous diacetylmorphine (DAM) plus oral methadone is better than a treatment with oral methadone alone on the physical and mental health and social integration of refractory opioid addicts.

Ethics approval

Ethics board of the Hospital Virgen de las Nieves, approved on 01/08/2001 (ref: 01/15.2)

Study design

Open randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Refractory opioid addicts

Intervention

Participants in the experimental group received DAM (heroin) injection twice a day, plus oral methadone once a day (to be taken at home) for 9 months. The control group received only oral methadone to be taken once a day.

Dosage:
The two groups received an equivalent opioid dose. Among treatment completers, an average DAM dosage of 274.5 mg/day (range: 15-600 mg) and an average methadone dosage of 42.6 mg/day (range 18-124 mg) were prescribed for the experimental group. The daily methadone dosage in the control group was 105 mg/day (range: 40-180 mg).

As a result, the approximate mean daily total equivalent dosage of DAM/day for the experimental group was between 395.5 and 414.5 mg/day; for the control group, it was between 361 and 400 mg/day.

Of the 62 participants, 44 completed the treatment and 50 patients were analysed.

Contact details of Principal Investigator:
Dr Joan Carles March
Andalusian School of Public Health (EASP)
Granada
18014, Spain
Tel: +34 958 027 400
Email: emilio.pereamilla@gmail.com

Intervention type

Drug

Phase

Not Applicable

Drug names

Diacetylmorphine (DAM; heroin), methadone

Primary outcome measures

A dichotomous multidimension outcome (MDO) index was determined by protocol as a primary outcome variable, imputing success when the patient showed at least 20% improvement at 9 months, compared with the baseline values, in general health or psychological or family adjustment, without a deterioration superior to 20% in any of these dimensions evaluated with the respective Addiction Severity Index (ASI) composite scores.

Secondary outcome measures

The following were assessed before randomisation, at 3, 6 and 9 months (end of the trial):
1. Physical and mental health, assessed by the Opiate Treatment Index (OTI), Symptom Checklist (SCL) and Maudsley Addiction Profile (MAP)
2. Psychosocial adjustment, assessed by the OTI and ASI
3. Treatment retention
4. Illegal activities, assessed by the ASI
5. Illicit drug use, assessed by the OTI and ASI
6. Quality of life, assessed by the Health Related Quality of Life 12-item Short Form (SF-12)

Overall trial start date

15/02/2003

Overall trial end date

15/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, 21 years or older
2. Long-term opioid-dependent persons who had not been benefited from other treatments

Potential participants were interviewed in squares, soup kitchens and methadone dispensaries by outreach workers and peers, who suggested they make an appointment with a PEPSA physician.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

62

Participant exclusion criteria

1. Non-agreement to participate
2. Psycho-social impairment to answer the questionnaires
3. Current medical, social or legal situation that is likely to result in an discontinuation period longer than the study period (9 months)

Recruitment start date

15/02/2003

Recruitment end date

15/12/2004

Locations

Countries of recruitment

Spain

Trial participating centre

School of Population and Public Health
Vancouver, BC
V6Z 1Y6
Canada

Sponsor information

Organisation

Drug Commission, Council for Equality and Social Welfare (Spain)

Sponsor details

C/o Andrés Estrada Moreno
Director General para las Drogodependencias y Adicciones
Consejería para la Igualdad y Bienestar Social
Junta de Andalucia
Avenida de Hytasa
14
Sevilla
41071
Spain
+34 955 048 000
DGDrogodependenciasyAdicciones.cibs@juntadeandalucia.es

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Committee on Drug Dependence, Carlos III Health Institute (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2004 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15228924
2. 2006 main results: http://www.ncbi.nlm.nih.gov/pubmed/16919749
3. 2007 review including data from this trial in http://www.ncbi.nlm.nih.gov/pubmed/17562183
4. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18299779
5. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19682360
2008 results, comparing the baseline data from Canadian sample with the European trials, including the data from this trial: http://www.ncbi.nlm.nih.gov/pubmed/18758964

Publication citations

  1. Results

    Perea-Milla E, Ayçaguer LC, Cerdà JC, Saiz FG, Rivas-Ruiz F, Danet A, Vallecillo MR, Oviedo-Joekes E, Efficacy of prescribed injectable diacetylmorphine in the Andalusian trial: Bayesian analysis of responders and non-responders according to a multi domain outcome index., Trials, 2009, 10, 70, doi: 10.1186/1745-6215-10-70.

  2. March JC, Oviedo-Joekes E, Romero M, Gómez M, Rodríguez S, León MI, Rodríguez C, , [The experimental drug prescription program in Andalusia [PEPSA]: procedure for recruiting participants]., Gac Sanit, 18, 3, 245-247.

  3. March JC, Oviedo-Joekes E, Perea-Milla E, Carrasco F, , Controlled trial of prescribed heroin in the treatment of opioid addiction., J Subst Abuse Treat, 2006, 31, 2, 203-211, doi: 10.1016/j.jsat.2006.04.007.

  4. Fischer B, Oviedo-Joekes E, Blanken P, Haasen C, Rehm J, Schechter MT, Strang J, van den Brink W, Heroin-assisted treatment (HAT) a decade later: a brief update on science and politics., J Urban Health, 2007, 84, 4, 552-562, doi: 10.1007/s11524-007-9198-y.

  5. de Arcos FA, Verdejo García A, López Jiménez A, Montañez Pareja M, Gómez Juárez E, Arráez Sánchez F, Pérez García M, [Emotional response to affective stimuli in subjects addicted to opiates engaged in controlled use as part of the P.E.P.S.A]., Adicciones, 2008, 20, 1, 27-35.

  6. Oviedo-Joekes E, Nosyk B, Brissette S, Chettiar J, Schneeberger P, Marsh DC, Krausz M, Anis A, Schechter MT, The North American Opiate Medication Initiative (NAOMI): profile of participants in North America's first trial of heroin-assisted treatment., J Urban Health, 2008, 85, 6, 812-825, doi: 10.1007/s11524-008-9312-9.

Additional files

Editorial Notes